MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, DRILL GUIDE, 4.3 MM; N/A

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: item: ncb, drill bit, 4.3 mm, 195 mm catalog #: 02.00024.002 lot #: unknown.The manufacturer did not receive x-rays, or other source documents for review.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).The following reports are associated with this event: 0009613350- 2020-00444.
Event or Problem Description
It was reported that the drill got stuck in the drill guide.Additional information has been requested.The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
Event description: it was reported that on sep 3, 2020, the drill got stuck in the drill guide.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination (drill bit and drill guide) was approved by zimmer biomet.Dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: it was reported that on sep 3, 2020, the drill got stuck in the drill guide.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).The device was not returned for examination, therefore, an investigation could not be performed, hence an exact root cause could not be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: NCB, DRILL GUIDE, 4.3 MM
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10619093
• Report Number: 0009613350-2020-00445
• Device Sequence Number: 14366557
• Product Code: FZX
• UDI-Device Identifier: 00889024289321
• UDI-Public: 00889024289321
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00024.011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other